EP3199555A4 - Formulation de protéines hybrides recombinantes - Google Patents

Formulation de protéines hybrides recombinantes Download PDF

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Publication number
EP3199555A4
EP3199555A4 EP15844336.6A EP15844336A EP3199555A4 EP 3199555 A4 EP3199555 A4 EP 3199555A4 EP 15844336 A EP15844336 A EP 15844336A EP 3199555 A4 EP3199555 A4 EP 3199555A4
Authority
EP
European Patent Office
Prior art keywords
fusion protein
recombinant fusion
protein formulation
formulation
recombinant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP15844336.6A
Other languages
German (de)
English (en)
Other versions
EP3199555B1 (fr
EP3199555A1 (fr
Inventor
Yinjue WANG
Junfeng Li
Xiaole HUANG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innovent Biologics Inc
Original Assignee
Innovent Biologics Inc
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Filing date
Publication date
Application filed by Innovent Biologics Inc filed Critical Innovent Biologics Inc
Publication of EP3199555A1 publication Critical patent/EP3199555A1/fr
Publication of EP3199555A4 publication Critical patent/EP3199555A4/fr
Application granted granted Critical
Publication of EP3199555B1 publication Critical patent/EP3199555B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/711—Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A61K38/1725—Complement proteins, e.g. anaphylatoxin, C3a or C5a
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70596—Molecules with a "CD"-designation not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
EP15844336.6A 2014-09-25 2015-09-25 Formulation de protéines hybrides recombinantes Active EP3199555B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201410498228.8A CN104940926B (zh) 2014-09-25 2014-09-25 重组融合蛋白制剂
PCT/CN2015/090778 WO2016045627A1 (fr) 2014-09-25 2015-09-25 Formulation de protéines hybrides recombinantes

Publications (3)

Publication Number Publication Date
EP3199555A1 EP3199555A1 (fr) 2017-08-02
EP3199555A4 true EP3199555A4 (fr) 2017-10-18
EP3199555B1 EP3199555B1 (fr) 2020-04-01

Family

ID=54156346

Family Applications (1)

Application Number Title Priority Date Filing Date
EP15844336.6A Active EP3199555B1 (fr) 2014-09-25 2015-09-25 Formulation de protéines hybrides recombinantes

Country Status (4)

Country Link
US (1) US10071136B2 (fr)
EP (1) EP3199555B1 (fr)
CN (1) CN104940926B (fr)
WO (1) WO2016045627A1 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105435222B (zh) 2014-09-25 2018-05-29 信达生物制药(苏州)有限公司 重组融合蛋白制剂
CN105412909B (zh) * 2015-11-27 2019-08-06 康立泰药业有限公司 一种重组人白细胞介素-12的溶液剂及其制备方法
CN106890313A (zh) * 2015-12-18 2017-06-27 信达生物制药(苏州)有限公司 用于治疗病理性近视的药物
CN108671229B (zh) * 2018-05-08 2022-03-25 华博生物医药技术（上海）有限公司 一种重组人血管内皮生长因子受体-抗体融合蛋白的药物组合制剂
MA52570A (fr) 2018-05-10 2021-03-17 Regeneron Pharma Formulations contenant des protéines de fusion du récepteur vegf à haute concentration
CN112206319A (zh) * 2019-07-12 2021-01-12 鲁南制药集团股份有限公司 一种cd47单克隆抗体制剂及其制备方法
AU2020414152A1 (en) * 2019-12-24 2022-08-04 Innovent Biologics (Suzhou) Co., Ltd. Application of fusion protein in treating age-related macular degeneration
JP2023535433A (ja) * 2020-07-23 2023-08-17 イノベント バイオロジクス（スーチョウ）カンパニー，リミティド Ｐｄ－ｌ１／ｌａｇ－３二重特異性抗体製剤およびその調製方法ならびに使用
CN114681592A (zh) * 2020-12-31 2022-07-01 天境生物科技(杭州)有限公司 包含可溶性gp130二聚体的制剂和使用方法
CN112816595A (zh) * 2021-01-06 2021-05-18 海默斯（重庆）医学生物技术有限公司 一种重组角蛋白液体制剂及其纯度检测方法
CN114306576A (zh) * 2022-01-11 2022-04-12 北京志道生物科技有限公司 一种防止il-2衍生物蛋白复合体聚集及非共价连接蛋白亚基脱落的制剂

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006104852A2 (fr) * 2005-03-25 2006-10-05 Regeneron Pharmaceuticals, Inc. Formulations d'antagonistes du facteur vegf
WO2007149334A2 (fr) * 2006-06-16 2007-12-27 Regeneron Pharmaceuticals, Inc. Formulations antagonistes du vegf appropriées à une administration intravitréenne
CN102380096A (zh) * 2010-08-31 2012-03-21 成都康弘生物科技有限公司 一种含有抑制血管增生的融合蛋白的药物组合物及用途
CN103212075A (zh) * 2012-01-19 2013-07-24 成都康弘生物科技有限公司 一种含有vegf拮抗剂的滴眼液
CN103816115A (zh) * 2010-08-31 2014-05-28 成都康弘生物科技有限公司 一种含有抑制血管增生的融合蛋白的药物组合物及用途

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2008118166A (ru) * 2005-11-22 2009-12-27 Вайет (Us) Составы, содержащие гибридные белки, включающие иммуноглобулин
CN110078831A (zh) * 2011-12-01 2019-08-02 圆祥生命科技股份有限公司 补体和vegf途径的蛋白质抑制剂及其使用方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006104852A2 (fr) * 2005-03-25 2006-10-05 Regeneron Pharmaceuticals, Inc. Formulations d'antagonistes du facteur vegf
WO2007149334A2 (fr) * 2006-06-16 2007-12-27 Regeneron Pharmaceuticals, Inc. Formulations antagonistes du vegf appropriées à une administration intravitréenne
CN102380096A (zh) * 2010-08-31 2012-03-21 成都康弘生物科技有限公司 一种含有抑制血管增生的融合蛋白的药物组合物及用途
CN103816115A (zh) * 2010-08-31 2014-05-28 成都康弘生物科技有限公司 一种含有抑制血管增生的融合蛋白的药物组合物及用途
CN103212075A (zh) * 2012-01-19 2013-07-24 成都康弘生物科技有限公司 一种含有vegf拮抗剂的滴眼液

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 201240, Derwent World Patents Index; AN 2012-D90894, XP002773544 *
DATABASE WPI Week 201407, Derwent World Patents Index; AN 2013-T74479, XP002773546 *
DATABASE WPI Week 201449, Derwent World Patents Index; AN 2014-N92029, XP002773545 *
See also references of WO2016045627A1 *
WANG: "Therapeutic Effect of IBI302, a bispecific Fc-fusion protein, on Age-related Macular Degeneration", 30 April 2014 (2014-04-30), pages 1 - 2, XP055404690, Retrieved from the Internet <URL:http://iovs.arvojournals.org/article.aspx?articleid=2266428> [retrieved on 20170907] *

Also Published As

Publication number Publication date
US10071136B2 (en) 2018-09-11
EP3199555B1 (fr) 2020-04-01
WO2016045627A1 (fr) 2016-03-31
EP3199555A1 (fr) 2017-08-02
CN104940926B (zh) 2017-09-22
US20180147258A1 (en) 2018-05-31
CN104940926A (zh) 2015-09-30

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